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

Model Number	FPRCH6000
Medical Device Problem Code	Insufficient Cooling (1130)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6) hospital.E1: initial reporter address 1: (b)(6).E1: initial reporter city: (b)(6).E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported insufficient ice occurred due to the console system.During preparation prior to the procedure, the channel(s) of the visual-ice cryoablation system did not freeze as expected.Additional information was requested through the good faith effort (gfe) process; however, no details have been received.There is no indication that a patient complication or serious harm occurred due to this event as the malfunction occurred prior to the procedure.

• Brand Name: VISUAL-ICE 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: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; 9529306396
• MDR Report Key: 24525053
• Report Number: 2124215-2026-12347
• Device Sequence Number: 18273286
• Product Code: GEH
• UDI-Device Identifier: 00867379000006
• UDI-Public: (01)00867379000006(11)221027(10)V50082
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2026

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
• Device Catalogue Number: FPRCH6000
• Device Lot Number: V50082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 05/20/2026
• Date Device Manufactured: 10/27/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown