MAUDE Adverse Event Report: BTG ROUND LAKE VISUAL-ICE CRYOABLATION SYSTEM US; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number	FPRCH6000-02
Medical Device Problem Codes	Insufficient Cooling (1130); Display or Visual Feedback Problem (1184); Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Good faith effort attempts were made to retrieve the device status, but it was unable to be obtained.
Event or Problem Description
It was reported that insufficient ice occurred.A visual-ice cryoablation system was selected for a cryoablation procedure.During the second freeze of the procedure, the console did not freeze as expected and insufficient ice occurred.It was noted that this issue has occurred with the same system on more than one occasion.There were no patient complications as a result of this event.

• Brand Name: VISUAL-ICE CRYOABLATION SYSTEM US
• 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: 21679785
• Report Number: 2124215-2025-17937
• Device Sequence Number: 20768549
• Product Code: GEH
• UDI-Device Identifier: 00859019006462
• UDI-Public: 00859019006462
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K113860
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2025

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: FPRCH6000-02
• Device Catalogue Number: FPRCH6000-02
• Device Lot Number: NVI0015
• 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: 02/26/2025
• Initial Report FDA Received Date: 03/24/2025
• Date Device Manufactured: 10/19/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown