510(k) Report

510(k) · Cleared

Cleared

Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System

K151054510(k) SpecialCleared Jul 7, 201578-day reviewClass II21 CFR 878.4350

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

C2 Therapeutics, Inc. · GEH Unit, Cryosurgical, Accessories

Cleared on Jul 7, 2015 as substantially equivalent to K131523 (C2 Therapeutics, 2013) after a 78-day review. Its family tree reaches back 7 generations to 1984. 8 later devices descend from it.

Decided
Jul 7, 2015
Review
78 days
Class
Class II
Product code
GEH
Recalls
None
Predicates
1

Its longest line of descent runs back 7 generations to K840536 (1984). 13 ancestors in all, the oldest K811390 (1981). 8 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor2002: 1 other ancestor1998: 1 other ancestor1994: 1 other ancestor1981: 2 other ancestors2016: 2 descendants cleared2017: 1 descendant cleared2018: 1 descendant cleared2019: 1 descendant cleared2020: 1 descendant cleared2021: 1 descendant cleared2024: 1 descendant clearedK840536 · Cryo Surg 5900 · Frigitronics of Connecticut, Inc. · 1984K970995 · CMS Cryolite · Cryomedical Sciences, Inc. · 1997K040809 · Crymed Cryo-Ablator · Crymed Technologies, Inc. · 2004K060555 · Spraygenix Cryo Ablation System · Crymed Technologies, Inc. · 2006K070893 · Cryospray Ablation System, Model CU 8407020500 · CSA Medical, Inc. · 2007K101825 · Cryoballoon Ablation System · C2 Therapeutics · 2010K131523 · Cryoballoon Focal Ablation System · C2 Therapeutics · 2013 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 3 generations back: 2 other ancestors4 generations back: 4 other ancestors 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant5 generations forward: 1 descendant6 generations forward: 1 descendant K131523 · Cryoballoon Focal Ablation System · C2 Therapeutics · 2013 · recalledK101825 · Cryoballoon Ablation System · C2 Therapeutics · 2010K070893 · Cryospray Ablation System, Model CU 8407020500 · CSA Medical, Inc. · 2007K060555 · Spraygenix Cryo Ablation System · Crymed Technologies, Inc. · 2006K040809 · Crymed Cryo-Ablator · Crymed Technologies, Inc. · 2004K970995 · CMS Cryolite · Cryomedical Sciences, Inc. · 1997K840536 · Cryo Surg 5900 · Frigitronics of Connecticut, Inc. · 1984−50+5
  1. Root · 7 generations backK840536 Cryo Surg 5900Frigitronics of Connecticut, Inc. · 1984
  2. 6 generations backK970995 CMS CryoliteCryomedical Sciences, Inc. · 1997
  3. 5 generations backK040809 Crymed Cryo-AblatorCrymed Technologies, Inc. · 2004
  4. 4 generations backK060555 Spraygenix Cryo Ablation SystemCrymed Technologies, Inc. · 2006
  5. 3 generations backK070893 Cryospray Ablation System, Model CU 8407020500CSA Medical, Inc. · 2007
  6. 2 generations backK101825 Cryoballoon Ablation SystemC2 Therapeutics · 2010
  7. 1 generation backK131523 Cryoballoon Focal Ablation SystemC2 Therapeutics · 2013 · Recalled
  8. This deviceK151054 Coldplay Full CryoBalloon Ablation System and Coldplay Swipe…C2 Therapeutics, Inc. · 2015
  9. Descendant · cites it directly · 6 of its ownK152329 Coldplay Cryoballoon; Focal Ablation System, Full Ablation System…C2 Therapeutics, Inc. · 2016 · Recalled
  10. Descendant · 2 generations on · 5 of its ownK161202 C2 Cryoballoon Ablation SystemC2 Therapeutics, Inc. · 2017 · Recalled
  11. Descendant · 2 generations on · 4 of its ownK163684 C2 CryoBalloon Ablation SystemC2 Therapeutics, Inc. · 2018 · Recalled
  12. 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
  13. Descendant · 4 generations on · 2 of its ownK203024 C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard)…Pentax of America, Inc. · 2020

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2016: 22017: 12018: 12019: 12020: 12021: 12024: 1
2016high 2 (2016) · low 0 (2022)2026

Most influential descendants

Showing 5 of 8 · See all
  • 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
  • K203024C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon…Pentax of America, Inc. · 2020 · 4 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K840536Cryo Surg 5900Frigitronics of Connecticut, Inc.1984—
−6K970995CMS CryoliteCryomedical Sciences, Inc.1997—
−5K040809Crymed Cryo-AblatorCrymed Technologies, Inc.2004—
−4K060555Spraygenix Cryo Ablation SystemCrymed Technologies, Inc.2006—
−3K070893Cryospray Ablation System, Model CU 8407020500CSA Medical, Inc.2007—
−2K101825Cryoballoon Ablation SystemC2 Therapeutics2010—
−1K131523Cryoballoon Focal Ablation SystemC2 Therapeutics20132
0 (this device)K151054Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon…C2 Therapeutics, Inc.2015—
+1K152329Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe…C2 Therapeutics, Inc.20161
+2K161202C2 Cryoballoon Ablation SystemC2 Therapeutics, Inc.20171
+2K163684C2 CryoBalloon Ablation SystemC2 Therapeutics, Inc.20184
+3K190194C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon…Pentax Medical, A Division of Pentax of America, Inc.2019—
+4K203024C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2…Pentax of America, Inc.2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198120
199410
199810
200210
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201620
201710
201810
201910
202010
202110
202410
FIG. 1 — Lineage of K151054, 1984–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K211099 Freeze’n Clear Skin Clinic Warts & Tagsscore 25.4 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K131523Cryoballoon Focal Ablation System
Summary page 4
…rgical Device 21 CFR§878.4350(a)(2) Regulatory Class: Class II Product Code: GEH III. PREDICATE DEVICE K131523, Cryoballoon Focal Ablation System This predicate has not been subject to a design-related recall. IV. DEVICE DESCR…
C2 Therapeutics20132

Also cleared against K131523: 2 other devices →

What descends from it? (8)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K152329Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation SystemC2 Therapeutics, Inc.20166
K153541Coldplay CryoBalloon® Ablation SystemC2 Therapeutics, Inc.20160

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 31 years and passes through 6 companies; a new generation was cleared every 2.9 years on median.
  • 1 of the 13 ancestors has a recall of any class.
  • Of its descendants, K152329 (C2 Therapeutics, Inc., 2016) has gone furthest, with 6 descendants of its own.
  • 2 other devices also cite its predicate K131523.

How does its category compare?

All GEH devices

GEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · GEH

10in 2025

2007: 62008: 12009: 42010: 42011: 72012: 42013: 42014: 62015: 112016: 152017: 122018: 62019: 62020: 82021: 62022: 62023: 82024: 92025: 102026 (partial year): 8
2007high 15 (2016) · low 1 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEH

77in 2025

2007: 71 days median2009: 121 days median2010: 86 days median2011: 91 days median2012: 96 days median2013: 76 days median2014: 42 days median2015: 72 days median2016: 60 days median2017: 83 days median2018: 42 days median2019: 115 days median2020: 113 days median2021: 206 days median2022: 56 days median2023: 136 days median2024: 85 days median2025: 77 days median2026 (partial year): 148 days median
2007high 206 (2021) · low 42 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEH

2in 2023

2007: 32008: 22009: 132010: 42012: 32014: 22018: 12019: 12020: 372023: 22026 (partial year): 2
2007high 37 (2020) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GEH

171in 2025

2007: 232008: 292009: 212010: 1732011: 612012: 912013: 912014: 572015: 972016: 1432017: 2162018: 2082019: 4552020: 2772021: 2132022: 2302023: 1642024: 1412025: 171
2007high 455 (2019) · low 21 (2009)2025

MAUDE reports naming product code GEH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007671323
20081—229
200941211321
20104864173
2011791061
2012496391
2013476091
2014642257
20151172097
201615600143
201712830216
20186421208
201961151455
2020811337277
202162060213
20226560230
202381362164
20249850141
202510770171
202681482—

What is it indicated for?

The Coldplay CryoBalloon 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 endoscopic applications.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K131523

2 other devices cite the same predicate.

  • K160994C2 CryoBalloon Focal Pear CatheterC2 Therapeutics, Inc. · 2016
  • K152329Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation SystemC2 Therapeutics, Inc. · 20161 recall

More from C2 Therapeutics, Inc.

7 FDA decisions under this applicant name. See the company

  • K163684C2 CryoBalloon Ablation SystemC2 Therapeutics, Inc. · 20184 recalls
  • K161202C2 Cryoballoon Ablation SystemC2 Therapeutics, Inc. · 20171 recall
  • K160994C2 CryoBalloon Focal Pear CatheterC2 Therapeutics, Inc. · 2016
  • K152329Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation SystemC2 Therapeutics, Inc. · 20161 recall
  • K153541Coldplay CryoBalloon® Ablation SystemC2 Therapeutics, Inc. · 2016

Recent decisions in GEH

The GEH category page

  • K262420Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)Serpex Medical · 2026
  • K261068Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)Serpex Medical · 2026
  • K261806ERBECRYO 2 Cryosurgical Unit and AccessoriesErbe Elektromedizin GmbH · 2026
  • K253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible CryoprobeErbe Elektromedizin GmbH · 2026
  • K252198Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)Medical Brands Laboratories B.V. · 2026

https://510kreport.com/device/K151054 · printed Nov 6, 2026

Cite this page

510(k) Report. “K151054: Coldplay Full CryoBalloon Ablation System and Coldplay Swipe 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/K151054

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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