510(k) · Cleared
ClearedColdplay 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 7, 2016 as substantially equivalent to K151054 (C2 Therapeutics, Inc., 2015) after a 28-day review. Its family tree reaches back 8 generations to 1984.
- Decided
- Jan 7, 2016
- Review
- 28 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K840536 (1984). 14 ancestors in all, the oldest K811390 (1981). No later device cites it as a predicate yet.
- Root · 8 generations backK840536 Cryo Surg 5900Frigitronics of Connecticut, Inc. · 1984
- 7 generations backK970995 CMS CryoliteCryomedical Sciences, Inc. · 1997
- 6 generations backK040809 Crymed Cryo-AblatorCrymed Technologies, Inc. · 2004
- 5 generations backK060555 Spraygenix Cryo Ablation SystemCrymed Technologies, Inc. · 2006
- 4 generations backK070893 Cryospray Ablation System, Model CU 8407020500CSA Medical, Inc. · 2007
- 3 generations backK101825 Cryoballoon Ablation SystemC2 Therapeutics · 2010
- 2 generations backK131523 Cryoballoon Focal Ablation SystemC2 Therapeutics · 2013 · Recalled
- 1 generation backK151054 Coldplay Full CryoBalloon Ablation System and Coldplay Swipe…C2 Therapeutics, Inc. · 2015
- This deviceK153541 Coldplay CryoBalloon® Ablation SystemC2 Therapeutics, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K840536 | Cryo Surg 5900 | Frigitronics of Connecticut, Inc. | 1984 | — |
| −7 | K970995 | CMS Cryolite | Cryomedical Sciences, Inc. | 1997 | — |
| −6 | K040809 | Crymed Cryo-Ablator | Crymed Technologies, Inc. | 2004 | — |
| −5 | K060555 | Spraygenix Cryo Ablation System | Crymed Technologies, Inc. | 2006 | — |
| −4 | K070893 | Cryospray Ablation System, Model CU 8407020500 | CSA Medical, Inc. | 2007 | — |
| −3 | K101825 | Cryoballoon Ablation System | C2 Therapeutics | 2010 | — |
| −2 | K131523 | Cryoballoon Focal Ablation System | C2 Therapeutics | 2013 | 2 |
| −1 | K151054 | Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon… | C2 Therapeutics, Inc. | 2015 | — |
| 0 (this device) | K153541 | Coldplay CryoBalloon® Ablation System | C2 Therapeutics, Inc. | 2016 | — |
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 |
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 |
|---|---|---|---|
| * | K151054 | Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation SystemSummary page 4…21 CFR§878.4350(a)(2) Regulatory Class: Class II Product Code: GEH III. PREDICATE DEVICE Coldplay CryoBalloon® Full Ablation System, K151054 This predicate has not been subject to a design-related recall. IV. DEVICE DESCRIPTION The modified device is… | 2015 |
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 32 years and passes through 6 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 14 ancestors has a recall of any class.
- 1 other device also cites its predicate K151054.
How does its category compare?
All GEH devicesGEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Coldplay CryoBalloon® Ablation System is intended for use as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153541 · printed Nov 5, 2026
Cite this page
510(k) Report. “K153541: Coldplay CryoBalloon® Ablation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153541
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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