MAUDE Adverse Event Report: BTG ROUND LAKE ICEFX CRYOABLATION SYSTEM; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number	FPRCH8000
Medical Device Problem Codes	Gas/Air Leak (2946); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the procedure was cancelled due to a gas leak.A icefx cryoablation system was chosen to treat endometriosis.General anesthesia was administered.An icerod cx 90 degree needle/vl passed testing correctly and was inserted into the patient for treatment.However, during the final check before the start of the procedure, a gas leak was observed at the back of the console at the level of the gas outlet.The system was shut down and restarted three times; however, the issue did not resolve.The procedure was cancelled as a result of the gas leak.There were no patient complications as a result of this event.
Event or Problem Description
It was reported the procedure was cancelled due to a gas leak.A icefx cryoablation system was chosen to treat endometriosis.General anesthesia was administered.An icerod cx 90 degree needle/vl passed testing correctly and was inserted into the patient for treatment.However, during the final check before the start of the procedure, a gas leak was observed at the back of the console at the level of the gas outlet.The system was shut down and restarted three times; however, the issue did not resolve.The procedure was cancelled as a result of the gas leak.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device evaluation by field service engineer: the icefx cryoablation system was not returned to boston scientific for analysis.The reported event was confirmed by the field service engineer (fse), the fse replaced the burst disk to repair the console and the issue was resolved.

• Brand Name: ICEFX CRYOABLATION SYSTEM
• Common Device Name: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): BTG ROUND LAKE; 4364 round lake road; arden hills MN 55112
• Manufacturer (Section G): GALIL MEDICAL; 4364 round lake road; arden hills MN 55112
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23173348
• Report Number: 2124215-2025-68581
• Device Sequence Number: 8882861
• Product Code: GEH
• UDI-Device Identifier: 00859019006370
• UDI-Public: (01)00859019006370(11)220808
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K181153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FPRCH8000
• Device Catalogue Number: FPRCH8000
• Device Lot Number: ICP0407
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 09/29/2025
• Supplement Report FDA Received Date: 12/18/2025
• Date Device Manufactured: 08/08/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female