510(k) · Cleared
Recalled · Class II · 2018Cryoballoon Focal Ablation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C2 Therapeutics · GEH Unit, Cryosurgical, Accessories
Cleared on Aug 22, 2013 as substantially equivalent to K101825 (C2 Therapeutics, 2010) after an 86-day review. Its family tree reaches back 6 generations to 1984. 10 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 22, 2013
- Review
- 86 days
- Class
- Class II
- Product code
- GEH
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 6 generations to K840536 (1984). 12 ancestors in all, the oldest K811390 (1981). 10 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK840536 Cryo Surg 5900Frigitronics of Connecticut, Inc. · 1984
- 5 generations backK970995 CMS CryoliteCryomedical Sciences, Inc. · 1997
- 4 generations backK040809 Crymed Cryo-AblatorCrymed Technologies, Inc. · 2004
- 3 generations backK060555 Spraygenix Cryo Ablation SystemCrymed Technologies, Inc. · 2006
- 2 generations backK070893 Cryospray Ablation System, Model CU 8407020500CSA Medical, Inc. · 2007
- 1 generation backK101825 Cryoballoon Ablation SystemC2 Therapeutics · 2010
- This deviceK131523 Cryoballoon Focal Ablation SystemC2 Therapeutics · 2013
- Descendant · cites it directly · 8 of its ownK151054 Coldplay Full CryoBalloon Ablation System and Coldplay Swipe…C2 Therapeutics, Inc. · 2015
- Descendant · cites it directly · 6 of its ownK152329 Coldplay Cryoballoon; Focal Ablation System, Full Ablation System…C2 Therapeutics, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 5 of its ownK161202 C2 Cryoballoon Ablation SystemC2 Therapeutics, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 4 of its ownK163684 C2 CryoBalloon Ablation SystemC2 Therapeutics, Inc. · 2018 · Recalled
- Descendant · 3 generations on · 3 of its ownK190194 C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2…Pentax Medical, A Division of Pentax of America, Inc. · 2019
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K151054Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation SystemC2 Therapeutics, Inc. · 2015 · cites it directly8descendants
- K152329Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation SystemC2 Therapeutics, Inc. · 2016 · cites it directly6descendants
- K161202C2 Cryoballoon Ablation SystemC2 Therapeutics, Inc. · 2017 · 2 generations on5descendants
- K163684C2 CryoBalloon Ablation SystemC2 Therapeutics, Inc. · 2018 · 2 generations on4descendants
- K190194C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2…Pentax Medical, A Division of Pentax of America, Inc. · 2019 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K840536 | Cryo Surg 5900 | Frigitronics of Connecticut, Inc. | 1984 | — |
| −5 | K970995 | CMS Cryolite | Cryomedical Sciences, Inc. | 1997 | — |
| −4 | K040809 | Crymed Cryo-Ablator | Crymed Technologies, Inc. | 2004 | — |
| −3 | K060555 | Spraygenix Cryo Ablation System | Crymed Technologies, Inc. | 2006 | — |
| −2 | K070893 | Cryospray Ablation System, Model CU 8407020500 | CSA Medical, Inc. | 2007 | — |
| −1 | K101825 | Cryoballoon Ablation System | C2 Therapeutics | 2010 | — |
| 0 (this device) | K131523 | Cryoballoon Focal Ablation System | C2 Therapeutics | 2013 | — |
| +1 | K151054 | Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon… | C2 Therapeutics, Inc. | 2015 | — |
| +1 | K152329 | Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe… | C2 Therapeutics, Inc. | 2016 | 1 |
| +2 | K161202 | C2 Cryoballoon Ablation System | C2 Therapeutics, Inc. | 2017 | 1 |
| +2 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 2 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K101825 | Cryoballoon Ablation SystemSummary page 1…CFR Classification: 21 CFR§878.4350(a)(2) Product Code: GEH Ill. Predicate Device * CryoBalloon Ablation System - K101825 IV. Product Description The CryoBalloon Focal Ablation System (modified device) is a cryosurgical unit… | 2010 |
What descends from it? (10)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 30, 2018 | Class II | Z-2256-2018 | Vendor change control | The catheter alignment arrow printed onto the strain relief is not aligned with the detachment feature of the catheter connector, resulting in the potential for the catheter to be attached to the controller in the detach orientation. In… |
| Jan 6, 2017 | Class II | Z-1477-2017 | Under Investigation by firm | The Controller Cap of the C2 CyroBalloon Ablation System may crack as it is tightened onto the controller. That could compromise the integrity and result in damage to the Controller Cap. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 5 companies; a new generation was cleared every 3.4 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K151054 (C2 Therapeutics, Inc., 2015) has gone furthest, with 8 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. 2013, 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 Therapeutics CryoBalloon Focal Ablation System is intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery. specifically for endloscopic applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131523 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131523: Cryoballoon Focal 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/K131523
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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