510(k) · Cleared
ClearedC2 CryoBalloon Ablation System (C2 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 Jul 24, 2024 as substantially equivalent to K212814 (Pentax of America, Inc., 2021) after a 159-day review. Its family tree reaches back 22 generations to 1995.
- Decided
- Jul 24, 2024
- Review
- 159 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 22 generations to K943450 (1995). 73 ancestors in all, the oldest K790187 (1979). No later device cites it as a predicate yet.
- Root · 22 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 18 generations between
- 3 generations backK190194 C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2…Pentax Medical, A Division of Pentax of America, Inc. · 2019
- 2 generations backK203024 C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard)…Pentax of America, Inc. · 2020
- 1 generation backK212814 C2 CryoBalloon Ablation SystemPentax of America, Inc. · 2021
- This deviceK240457 C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)Pentax of America, Inc. · 2024
Show all 22 generations
- Root · 22 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 21 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 20 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 19 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 18 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 17 generations backK013139 Stellartech Coagulation SystemStellartech Research Corp. · 2001
- 16 generations backK032062 Stellartech Coagulation System, Models (1100C-115 & 1100C-230)Stellartech Research Corp. · 2003
- 15 generations backK032452 Modification to: Stellartech Coagulation System, Models 1100C-115 &…Stellartech Research Corp. · 2003
- 14 generations backK032721 Modification to: Stellartech Coagulation System (Models 1100C-115 &…Stellartech Research Corp. · 2003
- 13 generations backK040240 Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp. · 2004
- 12 generations backK041383 Stellartech Coagulation System, Models 1100C-115 and 1100C-230Stellartech Research Corp. · 2004
- 11 generations backK042909 Stellartech Coagulation System, Models 1100C-115A & 1100C-230AStellartech Research Corp. · 2004
- 10 generations backK050831 Stellartech Coagulation System 2, Models 1100C-115A and 1100C-230AStellartech Research Corp. · 2005
- 9 generations backK060169 Barrx Halo Coagulation System, Barrx Halo Coagulation Generator…Barrx Medical, Incorporated · 2006
- 8 generations backK062723 HALO90 Coagulation CatheterBarrx Medical, Incorporated · 2006
- 7 generations backK083737 Halo Ablation CatheterBarrx Medical, Incorporated · 2009
- 6 generations backK152329 Coldplay Cryoballoon; Focal Ablation System, Full Ablation System…C2 Therapeutics, Inc. · 2016 · Recalled
- 5 generations backK161202 C2 Cryoballoon Ablation SystemC2 Therapeutics, Inc. · 2017 · Recalled
- 4 generations backK163684 C2 CryoBalloon Ablation SystemC2 Therapeutics, Inc. · 2018 · Recalled
- 3 generations backK190194 C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2…Pentax Medical, A Division of Pentax of America, Inc. · 2019
- 2 generations backK203024 C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard)…Pentax of America, Inc. · 2020
- 1 generation backK212814 C2 CryoBalloon Ablation SystemPentax of America, Inc. · 2021
- This deviceK240457 C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)Pentax of America, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −21 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −20 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −19 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −18 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −17 | K013139 | Stellartech Coagulation System | Stellartech Research Corp. | 2001 | — |
| −16 | K032062 | Stellartech Coagulation System, Models (1100C-115 & 1100C-230) | Stellartech Research Corp. | 2003 | — |
| −15 | K032452 | Modification to: Stellartech Coagulation System, Models 1100C-115 & 100C-230 | Stellartech Research Corp. | 2003 | — |
| −14 | K032721 | Modification to: Stellartech Coagulation System (Models 1100C-115 & 1100C-230) | Stellartech Research Corp. | 2003 | — |
| −13 | K040240 | Stellartech Coagulation System (Models 1100C-115 & 1100C-230) | Stellartech Research Corp. | 2004 | — |
| −12 | K041383 | Stellartech Coagulation System, Models 1100C-115 and 1100C-230 | Stellartech Research Corp. | 2004 | — |
| −11 | K042909 | Stellartech Coagulation System, Models 1100C-115A & 1100C-230A | Stellartech Research Corp. | 2004 | — |
| −10 | K050831 | Stellartech Coagulation System 2, Models 1100C-115A and 1100C-230A | Stellartech Research Corp. | 2005 | — |
| −9 | K060169 | Barrx Halo Coagulation System, Barrx Halo Coagulation Generator, Barrx… | Barrx Medical, Incorporated | 2006 | — |
| −8 | K062723 | HALO90 Coagulation Catheter | Barrx Medical, Incorporated | 2006 | — |
| −7 | K083737 | Halo Ablation Catheter | Barrx Medical, Incorporated | 2009 | — |
| −6 | K152329 | Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe… | C2 Therapeutics, Inc. | 2016 | 1 |
| −5 | K161202 | C2 Cryoballoon Ablation System | C2 Therapeutics, Inc. | 2017 | 1 |
| −4 | K163684 | C2 CryoBalloon Ablation System | C2 Therapeutics, Inc. | 2018 | 4 |
| −3 | 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 | — |
| −1 | K212814 | C2 CryoBalloon Ablation System | Pentax of America, Inc. | 2021 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K212814 | C2 CryoBalloon Ablation SystemSummary page 4…ries Classification Name: Cryosurgical Unit and Accessories Regulatory Class: 21 CFR §878.4350 Product Code: GEH III. PREDICATE DEVICE C2 CryoBalloon Ablation System, K212814 IV. REFERENCE DEVICE BARRX Medical HALO90 System, K093008 V. DEVICE DESCRIPTION The subject device is a cryosurgical unit wit… | 2021 |
| † | K093008 | Halo Ablation Catheter, Model 90-9100 | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 6 companies; a new generation was cleared every 1.0 years on median.
- 9 of the 73 ancestors have a recall of any class.
How does its category compare?
All GEH devicesGEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 to be used as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications, to include ablation of Barrett’s Esophagus with dysplasia and treatment and management of Gastric Antral Vascular Ectasia (GAVE).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240457 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240457: C2 CryoBalloon Ablation System (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/K240457
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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