510(k) · Cleared
ClearedC2 CryoBalloon Ablation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pentax of America, Inc. · GEH Unit, Cryosurgical, Accessories
Cleared on Nov 29, 2021 as substantially equivalent to K203024 (Pentax of America, Inc., 2020) after an 87-day review. Its family tree reaches back 21 generations to 1995. 1 later device descends from it.
- Decided
- Nov 29, 2021
- Review
- 87 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 21 generations to K943450 (1995). 72 ancestors in all, the oldest K790187 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 21 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 17 generations between
- 3 generations backK163684 C2 CryoBalloon Ablation SystemC2 Therapeutics, Inc. · 2018 · Recalled
- 2 generations backK190194 C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2…Pentax Medical, A Division of Pentax of America, Inc. · 2019
- 1 generation backK203024 C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard)…Pentax of America, Inc. · 2020
- This deviceK212814 C2 CryoBalloon Ablation SystemPentax of America, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK240457 C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)Pentax of America, Inc. · 2024
Show all 21 generations
- Root · 21 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 20 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 19 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 18 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 17 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 16 generations backK013139 Stellartech Coagulation SystemStellartech Research Corp. · 2001
- 15 generations backK032062 Stellartech Coagulation System, Models (1100C-115 & 1100C-230)Stellartech Research Corp. · 2003
- 14 generations backK032452 Modification to: Stellartech Coagulation System, Models 1100C-115 &…Stellartech Research Corp. · 2003
- 13 generations backK032721 Modification to: Stellartech Coagulation System (Models 1100C-115 &…Stellartech Research Corp. · 2003
- 12 generations backK040240 Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp. · 2004
- 11 generations backK041383 Stellartech Coagulation System, Models 1100C-115 and 1100C-230Stellartech Research Corp. · 2004
- 10 generations backK042909 Stellartech Coagulation System, Models 1100C-115A & 1100C-230AStellartech Research Corp. · 2004
- 9 generations backK050831 Stellartech Coagulation System 2, Models 1100C-115A and 1100C-230AStellartech Research Corp. · 2005
- 8 generations backK060169 Barrx Halo Coagulation System, Barrx Halo Coagulation Generator…Barrx Medical, Incorporated · 2006
- 7 generations backK062723 HALO90 Coagulation CatheterBarrx Medical, Incorporated · 2006
- 6 generations backK083737 Halo Ablation CatheterBarrx Medical, Incorporated · 2009
- 5 generations backK152329 Coldplay Cryoballoon; Focal Ablation System, Full Ablation System…C2 Therapeutics, Inc. · 2016 · Recalled
- 4 generations backK161202 C2 Cryoballoon Ablation SystemC2 Therapeutics, Inc. · 2017 · Recalled
- 3 generations backK163684 C2 CryoBalloon Ablation SystemC2 Therapeutics, Inc. · 2018 · Recalled
- 2 generations backK190194 C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2…Pentax Medical, A Division of Pentax of America, Inc. · 2019
- 1 generation backK203024 C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard)…Pentax of America, Inc. · 2020
- This deviceK212814 C2 CryoBalloon Ablation SystemPentax of America, Inc. · 2021
Most influential descendants
Showing 1 of 1 · See all- K240457C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)Pentax of America, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −20 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −19 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −18 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −17 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −16 | K013139 | Stellartech Coagulation System | Stellartech Research Corp. | 2001 | — |
| −15 | K032062 | Stellartech Coagulation System, Models (1100C-115 & 1100C-230) | Stellartech Research Corp. | 2003 | — |
| −14 | K032452 | Modification to: Stellartech Coagulation System, Models 1100C-115 & 100C-230 | Stellartech Research Corp. | 2003 | — |
| −13 | K032721 | Modification to: Stellartech Coagulation System (Models 1100C-115 & 1100C-230) | Stellartech Research Corp. | 2003 | — |
| −12 | K040240 | Stellartech Coagulation System (Models 1100C-115 & 1100C-230) | Stellartech Research Corp. | 2004 | — |
| −11 | K041383 | Stellartech Coagulation System, Models 1100C-115 and 1100C-230 | Stellartech Research Corp. | 2004 | — |
| −10 | K042909 | Stellartech Coagulation System, Models 1100C-115A & 1100C-230A | Stellartech Research Corp. | 2004 | — |
| −9 | K050831 | Stellartech Coagulation System 2, Models 1100C-115A and 1100C-230A | Stellartech Research Corp. | 2005 | — |
| −8 | K060169 | Barrx Halo Coagulation System, Barrx Halo Coagulation Generator, Barrx… | Barrx Medical, Incorporated | 2006 | — |
| −7 | K062723 | HALO90 Coagulation Catheter | Barrx Medical, Incorporated | 2006 | — |
| −6 | K083737 | Halo Ablation Catheter | Barrx Medical, Incorporated | 2009 | — |
| −5 | K152329 | Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe… | C2 Therapeutics, Inc. | 2016 | 1 |
| −4 | K161202 | C2 Cryoballoon Ablation System | C2 Therapeutics, Inc. | 2017 | 1 |
| −3 | K163684 | C2 CryoBalloon Ablation System | C2 Therapeutics, Inc. | 2018 | 4 |
| −2 | K190194 | C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon… | Pentax Medical, A Division of Pentax of America, Inc. | 2019 | — |
| −1 | K203024 | C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2… | Pentax of America, Inc. | 2020 | — |
| 0 (this device) | K212814 | C2 CryoBalloon Ablation System | Pentax of America, Inc. | 2021 | — |
| +1 | 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 |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K203024 | C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon…Summary page 4…FR§878.4350(a)(2) Regulatory Class: Class II Product Code: GEH II. PREDICATE DEVICE: C2 CryoBalloon Ablation System, PENTAX Medical (K203024) III. DEVICE DESCRIPTION The subject device is a cryosurgical unit with a nitrous oxide cooled balloon that is… | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240457 | C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 6 companies; a new generation was cleared every 9 months on median.
- 9 of the 72 ancestors have a recall of any class.
- Of its descendants, K240457 (Pentax of America, Inc., 2024) has gone furthest, with 0 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. 2021, 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/K212814 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212814: C2 CryoBalloon Ablation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212814
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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