510(k) · Cleared
Recalled · Class II · 2018C2 CryoBalloon Ablation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C2 Therapeutics, Inc. · GEH Unit, Cryosurgical, Accessories
Cleared on Jan 23, 2018 as substantially equivalent to K161202 (C2 Therapeutics, Inc., 2017) and 1 other predicate after a 391-day review. Its family tree reaches back 18 generations to 1995. 4 later devices descend from it. It has been recalled 4 times.
- Decided
- Jan 23, 2018
- Review
- 391 days
- Class
- Class II
- Product code
- GEH
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 18 generations to K943450 (1995). 69 ancestors in all, the oldest K790187 (1979). 4 later devices descend from it, 1 citing it directly.
- Root · 18 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 14 generations between
- 3 generations backK083737 Halo Ablation CatheterBarrx Medical, Incorporated · 2009
- 2 generations backK152329 Coldplay Cryoballoon; Focal Ablation System, Full Ablation System…C2 Therapeutics, Inc. · 2016 · Recalled
- 1 generation backK161202 C2 Cryoballoon Ablation SystemC2 Therapeutics, Inc. · 2017 · Recalled
- This deviceK163684 C2 CryoBalloon Ablation SystemC2 Therapeutics, Inc. · 2018
- Descendant · cites it directly · 3 of its ownK190194 C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2…Pentax Medical, A Division of Pentax of America, Inc. · 2019
- Descendant · 2 generations on · 2 of its ownK203024 C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard)…Pentax of America, Inc. · 2020
- Descendant · 3 generations on · 1 of its ownK212814 C2 CryoBalloon Ablation SystemPentax of America, Inc. · 2021
- Descendant · 4 generations on · 0 of its ownK240457 C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)Pentax of America, Inc. · 2024
Show all 18 generations
- Root · 18 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 17 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 16 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 15 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 14 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 13 generations backK013139 Stellartech Coagulation SystemStellartech Research Corp. · 2001
- 12 generations backK032062 Stellartech Coagulation System, Models (1100C-115 & 1100C-230)Stellartech Research Corp. · 2003
- 11 generations backK032452 Modification to: Stellartech Coagulation System, Models 1100C-115 &…Stellartech Research Corp. · 2003
- 10 generations backK032721 Modification to: Stellartech Coagulation System (Models 1100C-115 &…Stellartech Research Corp. · 2003
- 9 generations backK040240 Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp. · 2004
- 8 generations backK041383 Stellartech Coagulation System, Models 1100C-115 and 1100C-230Stellartech Research Corp. · 2004
- 7 generations backK042909 Stellartech Coagulation System, Models 1100C-115A & 1100C-230AStellartech Research Corp. · 2004
- 6 generations backK050831 Stellartech Coagulation System 2, Models 1100C-115A and 1100C-230AStellartech Research Corp. · 2005
- 5 generations backK060169 Barrx Halo Coagulation System, Barrx Halo Coagulation Generator…Barrx Medical, Incorporated · 2006
- 4 generations backK062723 HALO90 Coagulation CatheterBarrx Medical, Incorporated · 2006
- 3 generations backK083737 Halo Ablation CatheterBarrx Medical, Incorporated · 2009
- 2 generations backK152329 Coldplay Cryoballoon; Focal Ablation System, Full Ablation System…C2 Therapeutics, Inc. · 2016 · Recalled
- 1 generation backK161202 C2 Cryoballoon Ablation SystemC2 Therapeutics, Inc. · 2017 · Recalled
- This deviceK163684 C2 CryoBalloon Ablation SystemC2 Therapeutics, Inc. · 2018
Most influential descendants
Showing 4 of 4 · See all- K190194C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2…Pentax Medical, A Division of Pentax of America, Inc. · 2019 · cites it directly3descendants
- K203024C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon…Pentax of America, Inc. · 2020 · 2 generations on2descendants
- K212814C2 CryoBalloon Ablation SystemPentax of America, Inc. · 2021 · 3 generations on1descendant
- K240457C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)Pentax of America, Inc. · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −17 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −16 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −15 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −14 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −13 | K013139 | Stellartech Coagulation System | Stellartech Research Corp. | 2001 | — |
| −12 | K032062 | Stellartech Coagulation System, Models (1100C-115 & 1100C-230) | Stellartech Research Corp. | 2003 | — |
| −11 | K032452 | Modification to: Stellartech Coagulation System, Models 1100C-115 & 100C-230 | Stellartech Research Corp. | 2003 | — |
| −10 | K032721 | Modification to: Stellartech Coagulation System (Models 1100C-115 & 1100C-230) | Stellartech Research Corp. | 2003 | — |
| −9 | K040240 | Stellartech Coagulation System (Models 1100C-115 & 1100C-230) | Stellartech Research Corp. | 2004 | — |
| −8 | K041383 | Stellartech Coagulation System, Models 1100C-115 and 1100C-230 | Stellartech Research Corp. | 2004 | — |
| −7 | K042909 | Stellartech Coagulation System, Models 1100C-115A & 1100C-230A | Stellartech Research Corp. | 2004 | — |
| −6 | K050831 | Stellartech Coagulation System 2, Models 1100C-115A and 1100C-230A | Stellartech Research Corp. | 2005 | — |
| −5 | K060169 | Barrx Halo Coagulation System, Barrx Halo Coagulation Generator, Barrx… | Barrx Medical, Incorporated | 2006 | — |
| −4 | K062723 | HALO90 Coagulation Catheter | Barrx Medical, Incorporated | 2006 | — |
| −3 | K083737 | Halo Ablation Catheter | Barrx Medical, Incorporated | 2009 | — |
| −2 | K152329 | Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe… | C2 Therapeutics, Inc. | 2016 | 1 |
| −1 | K161202 | C2 Cryoballoon Ablation System | C2 Therapeutics, Inc. | 2017 | 1 |
| 0 (this device) | K163684 | C2 CryoBalloon Ablation System | C2 Therapeutics, Inc. | 2018 | — |
| +1 | K190194 | C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon… | Pentax Medical, A Division of Pentax of America, Inc. | 2019 | — |
| +2 | K203024 | C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2… | Pentax of America, Inc. | 2020 | — |
| +3 | K212814 | C2 CryoBalloon Ablation System | Pentax of America, Inc. | 2021 | — |
| +4 | K240457 | C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) | Pentax of America, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 2 | 0 |
| 1984 | 2 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 5 | 0 |
| 1997 | 5 | 0 |
| 1998 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 5 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2010 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEH device
- #1 K211099 Freeze’n Clear Skin Clinic Warts & Tagsscore 25.4 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K161202 | C2 Cryoballoon Ablation System Cleared while this submission was under review Summary page 4…Class: Class II Product Code: GEH III. PREDICATE DEVICE Predicate Devices: Primary: C2 Therapeutics, Inc. (K161202) C2 CryoBalloon™ Ablation System Secondary:… | 2017 |
| * | K152329 | Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation SystemSummary page 4…Inc. (K161202) C2 CryoBalloon™ Ablation System Secondary: C2 Therapeutics, Inc. (K152329) Coldplay CryoBalloon™ Focal Ablation System Coldplay CryoBalloon™ Full… | 2016 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190194 | C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2… | 2019 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 3, 2018 | Class II | Z-0970-2019 | Nonconforming Material/Component | The Controller does not detect overpressure in the balloon during the application of non-dosing puffs of Nitrous Oxide, which can contribute to balloon over pressurization, if the intended vent lumen of the catheter is significantly… |
| Dec 3, 2018 | Class II | Z-1326-2019 | Under Investigation by firm | Incorrect default dose and dose increments may be transmitted to the controller if the catheter RFID tag is not correct or is not being correctly or completely readable by the controller. |
| Dec 3, 2018 | Class II | Z-1327-2019 | Under Investigation by firm | Incorrect default dose and dose increments may be transmitted to the controller if the catheter RFID tag is not correct or is not being correctly or completely readable by the controller. |
| Dec 3, 2018 | Class II | Z-1325-2019 | Under Investigation by firm | Incorrect default dose and dose increments may be transmitted to the controller if the catheter RFID tag is not correct or is not being correctly or completely readable by the controller. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 8 months on median.
- 8 of the 69 ancestors have a recall of any class.
- Of its descendants, K190194 (Pentax Medical, A Division of Pentax of America, Inc., 2019) has gone furthest, with 3 descendants of its own.
How does its category compare?
All GEH devicesGEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · GEH
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEH
77in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEH
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GEH
171in 2025
MAUDE reports naming product code GEH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 71 | 3 | 23 |
| 2008 | 1 | — | 2 | 29 |
| 2009 | 4 | 121 | 13 | 21 |
| 2010 | 4 | 86 | 4 | 173 |
| 2011 | 7 | 91 | 0 | 61 |
| 2012 | 4 | 96 | 3 | 91 |
| 2013 | 4 | 76 | 0 | 91 |
| 2014 | 6 | 42 | 2 | 57 |
| 2015 | 11 | 72 | 0 | 97 |
| 2016 | 15 | 60 | 0 | 143 |
| 2017 | 12 | 83 | 0 | 216 |
| 2018 | 6 | 42 | 1 | 208 |
| 2019 | 6 | 115 | 1 | 455 |
| 2020 | 8 | 113 | 37 | 277 |
| 2021 | 6 | 206 | 0 | 213 |
| 2022 | 6 | 56 | 0 | 230 |
| 2023 | 8 | 136 | 2 | 164 |
| 2024 | 9 | 85 | 0 | 141 |
| 2025 | 10 | 77 | 0 | 171 |
| 2026 | 8 | 148 | 2 | — |
What is it indicated for?
The C2 CryoBalloon™ Ablation System is intended for use as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications, to include ablation of Barrett’s Esophagus with dysplasia.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K163684 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163684: C2 CryoBalloon Ablation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163684
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026